Cardiac SurgeryRETROCARNCT04979754
REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In this retrospective study, the authors assess long term renal outcome in renal transplant recipients after cardiac surgery with cardiopulmonary bypass, and research factors associated with poor long term renal outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, Renal Transplant Recipient
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive renal transplant récipients, apparied in a 1:2 ratio with non renal transplant récipients, undergoing cardiac surgery, and meeting the protocol criteria between january 2010 and december 2019, in university hospital of Bordeaux.
Who may be able to join
- Previous renal transplantation
- Who underwent cardiac surgery with CPB
- Inclusion Criteria for Non Renal Transplant Récipients group:
- No previous renal transplantation
- Who underwent cardiac surgery with CPB
- Apparied with Renal Transplant récipients with the 5 following criteria : age, sex, previous diagnosis of diabete, type of cardiac surgery (isolated coronary artery bypass graft, valvular surgery, aorta surgery, combined surgery), best glomerular filtration rate with CKD-EPI formula at +/- 15 ml/min, in the 3 pre-operative months
Who cannot join
- Patients requiring mechanical circulatory support (Extracorporeal Membrane Oxygenation)
- Pre-operative permanent dialysis
- Aorta dissection extended to renal arteries
- Non-elective surgery for infective endocarditis
- Previous hepatic, pancreatic or cardiac transplantation
- Death in the 30 first days after cardiac surgery
- Patient not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Renal Outcome After Cardiac Surgery : Impact of Previous Renal Transplantation
In this retrospective study, the authors assess long term renal outcome in renal transplant recipients after cardiac surgery with cardiopulmonary bypass, and research factors associated with poor long term renal outcome.
Read the detailed description
Post-operative mortality after cardiac surgery is increased in renal transplant recipients, compared with general population of cardiac surgery, or with kidney transplant recipients not undergoing cardiac surgery. If the survival of this specific population is now well studied, the long-term renal outcome is much less studied. Previous studies show a trend for increased risk of allograft dysfunction and need for permanent dialysis. This study proposes to compare long term renal outcome between renal transplant recipients and non-renal transplant recipients.
- Being tested
- standard of care
- Keywords
- cardiac surgery, renal transplant recipient, renal function, acute kidney injury, major adverse kidney events
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
retrospective study : standard of care
| Study group | Role | What they receive |
|---|---|---|
| RENAL TRANSPLANT RECIPIENTS | All patients with previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass Receives: Other: standard of care | |
| NON RENAL TRANSPLANT RECIPIENTS | All patients without previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term renal outcome
Proportion of patients meeting a composite criterion : death or permanent dialysis or doubling the baseline serum creatinine value
Measured: 12 months after surgery
Secondary outcomes (4)
Glomerular Filtration Rate (GFR)
Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula
Measured: 30 days after surgery
Glomerular Filtration Rate (GFR)
Glomerular Filtration Rate (GFR) calculated with CKD-EPI formula
Measured: 12 months after surgery
Vital status
Mortality after surgery
Measured: 12 months after surgery
Major Adverse Kidney Events
Major Adverse Kidney Events defined by new receipt of Renal replacement therapy (RRT), or Acute Kidney Injury (AKI) episodes with persistent renal dysfunction and final serum creatinine value before hospital discharge ≥ 200 % of the baseline serum creatinine
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Nov 2020
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Ouattara, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979754
- Sponsor's protocol ID
- SAR Sud study one
- Acronym
- RETROCAR
- Status last verified
- Dec 2021
- First submitted
- 5 Jul 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Renal Outcome After Cardiac Surgery : Impact of Previous Renal Transplantation
- ClinicalTrials.gov ID
- NCT04979754
- Acronym / sponsor ID
- RETROCAR / SAR Sud study one
- Keywords
- cardiac surgery, renal transplant recipient, renal function, acute kidney injury, major adverse kidney events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this retrospective study, the authors assess long term renal outcome in renal transplant recipients after cardiac surgery with cardiopulmonary bypass, and research factors associated with poor long term renal outcome.
Detailed description
Post-operative mortality after cardiac surgery is increased in renal transplant recipients, compared with general population of cardiac surgery, or with kidney transplant recipients not undergoing cardiac surgery. If the survival of this specific population is now well studied, the long-term renal outcome is much less studied. Previous studies show a trend for increased risk of allograft dysfunction and need for permanent dialysis. This study proposes to compare long term renal outcome between renal transplant recipients and non-renal transplant recipients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RENAL TRANSPLANT RECIPIENTS | – | Other: standard of careAll patients with previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass |
| NON RENAL TRANSPLANT RECIPIENTS | – | Other: standard of careAll patients without previous renal transplantation undergoing cardiac surgery with cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive renal transplant récipients, apparied in a 1:2 ratio with non renal transplant récipients, undergoing cardiac surgery, and meeting the protocol criteria between january 2010 and december 2019, in university hospital of Bordeaux.
Key inclusion criteria (6 listed)
- Previous renal transplantation
- Who underwent cardiac surgery with CPB
- No previous renal transplantation
- Who underwent cardiac surgery with CPB
- Apparied with Renal Transplant récipients with the 5 following criteria : age, sex, previous diagnosis of diabete, type of cardiac surgery (isolated coronary artery bypass graft, valvular surgery, aorta surgery, combined surgery), best glomerular filtration rate with CKD-EPI formula at +/- 15 ml/min, in the 3 pre-operative months
Key exclusion criteria (7 listed)
- Patients requiring mechanical circulatory support (Extracorporeal Membrane Oxygenation)
- Pre-operative permanent dialysis
- Aorta dissection extended to renal arteries
- Non-elective surgery for infective endocarditis
- Previous hepatic, pancreatic or cardiac transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of careretrospective study : standard of care | Other | NON RENAL TRANSPLANT RECIPIENTS, RENAL TRANSPLANT RECIPIENTS |
Primary outcome
Long-term renal outcome
Time frame: 12 months after surgery
Proportion of patients meeting a composite criterion : death or permanent dialysis or doubling the baseline serum creatinine value
4 secondary outcomes
Glomerular Filtration Rate (GFR)
Time frame: 30 days after surgery
Glomerular Filtration Rate (GFR)
Time frame: 12 months after surgery
Vital status
Time frame: 12 months after surgery
Major Adverse Kidney Events
Time frame: Up to 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term renal outcome (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.